Machine Guarding for the Pharmaceutical Industry
Steve Allen, a Member of standards committee BSI MCE/3 (Safeguarding of machinery), a Certified Machinery Safety Expert and National Sales Manager at Procter Machine Safety, explains the requirements for guarding machinery in the pharmaceutical industry in order to comply with the law and provide protection during normal operation, cleaning and maintenance.
Machine Guarding for the Pharmaceutical Industry
Pharmaceutical manufacturing is more highly regulated than most other manufacturing industries and, arguably, more care is taken when designing production and packaging for use in this industry. Nevertheless, statistics from the HSE (Health and Safety Executive) show that there is scope to improve health and safety in this sector. For instance, in 2018/19 there was one fatality and 134 reportable non-fatal injuries.
This equates to 118 reportable non-fatal injuries per 100,000 employees, which is lower than most manufacturing industries and lower than the 254 per 100,000 ‘all industries’ average, but it clearly shows there is room for improvement.
The types of machinery encountered in the pharmaceutical industry range from mixers, tableting machines and capsule filling machines, through to belt conveyors, pneumatic conveyors and packaging machines. Indeed, the HSE states that the pharmaceutical industry is the second largest user of packaging machines after the food and drink industry.
Why is machine guarding required?
Obvious machine hazards are moving parts and entrapment between moving parts and fixed parts. Other hazards relate to hot and cold surfaces, noise, and contact with or inhalation of active ingredients and pharmaceutical raw materials.
Notwithstanding the strong moral argument for installing machine guards to protect workers, there are also legal obligations on employers. Furthermore, machine guarding also reduces the risk of product contamination and cuts noise emissions.
Machine guards prevent accidents and, therefore, can save money for manufacturers.
The true cost of an accident can be substantial, as it might include not only fines and costs imposed by the courts, but also equipment damage, downtime, lost production, absence of key workers due to injury or ill health, additional training costs, extra overtime, loss of reputation, management time and resources for the investigation and prosecution, and higher premiums for employers’ liability insurance.
What does the law say about machine guarding?
Under the European Union’s Machinery Directive, which is implemented in the UK as The Supply of Machinery (Safety) Regulations 2008 as amended, new machines must be CE marked to indicate their compliance – which includes preventing access to hazardous parts of machinery. Although the UK has now left the EU and is currently in a transition period it is expected that the UK’s machinery safety regulations from 2021 onwards will be all but identical to those currently in place, regardless of whether or not new trade arrangements are agreed.
In addition, the Provision and User of Work Equipment Regulations (PUWER) requires new equipment to be inspected prior to being put into use for the first time and periodically thereafter. Regulation 11 of PUWER addresses the needs relating to dangerous parts of machinery. In essence, regulation 11 (1) requires employers to take effective measures to prevent access to dangerous parts of machinery or to stop the movement of dangerous parts before any part of a person enters a danger zone, while regulation 11 (3) lays down specific requirements for guards and protection devices.
While the Machinery Directive places the onus on machine builders or suppliers and PUWER requires employers to ensure machinery is safe to use, employers are also obliged to comply with general health and safety legislation. Broadly speaking, The Health and Safety at Work Act places a responsibility on employers to protect workers and others from risks to their health, safety and welfare. This is the primary piece of legislation covering occupational health and safety in Great Britain. Under The Management of Health and Safety at Work Regulations 1999, employers (and self-employed people) are required to carry out a suitable and sufficient risk assessment of their activities, after which risks can be eliminated or reduced as far as is reasonably practicable. These risk assessments also need to be reviewed regularly.
Which standards do machine guards need to comply with?
There is no legal obligation to adhere to current standards but standards-compliant machine guarding will almost certainly provide the right level of protection. Furthermore, should an accident occur and the guards can be shown to meet the standards, it could be argued that ‘best practice’ was followed and reasonable measures had been taken with respect to machine guarding.
Numerous standards are relevant to guarding for pharmaceutical manufacturing and packaging machinery but the following are the most important (note that standards for pharmaceutical machinery are normally the same as those applied to machinery for manufacturing and packaging food, drink and cosmetics):
- BS EN ISO 12100:2010 ‘Safety of machinery. General principles for design. Risk assessment and risk reduction’
- BS EN ISO 14120:2015 ‘Safety of machinery. Guards. General requirements for the design and construction of fixed and movable guards’
- BS EN ISO 13857:2008 ‘Safety of machinery. Safety distances to prevent hazard zones being reached by upper and lower limbs’
- BS EN 1672-1 ‘Food processing machinery. Basic concepts. Safety requirements’
- BS EN 1672-2 ‘Food processing machinery. Basic concepts. Hygiene requirements’
Although it is not a standard, PD 5304:2014 ‘Guidance on the safe use of machinery’ is a Published Document from BSI. It has evolved from BS 5304:1988, the old British Standard for machinery safety, and contains a wealth of useful guidance and practical examples of guard design. Many of today’s international machinery safety standards incorporate principles contained in PD 5304 but they lack the illustrative examples found in the Published Document.
For a detailed guide to machine guarding standards, see the Useful Resources section below. The definitive list of standards harmonised to the Machinery Directive – including the ‘type C’ (machine-specific) standards – is available via the European Commission’s website.
Risk assessment and risk reduction
During the machine design phase, a formal risk assessment should be undertaken and documented. One aspect of this should be an assessment of whether any moving machinery can be accessed while the guards are in place. If moving parts can be accessed and the risks are assessed as unacceptable, steps must be taken to reduce the risks. Once the risk reduction measures are in place a confirmatory risk assessment is required to check that risks have been reduced sufficiently. If they have not, additional measures will be necessary.
Similarly, if guards are being retrofitted to machinery because the existing guarding is inadequate, then a risk assessment is vital. Indeed, a risk assessment should be the basis of any safety-related inspection or examination of machinery.
The British standard for machine risk assessments is BS EN ISO 12100:2010 (see above).
Machine guard design principles
For preventing access to dangerous parts of machines, the accepted hierarchical approach is as follows:
- design-out the hazards;
- use fixed guards where access is not required for routine examination and maintenance; and
- use removable guards for areas where access is required for routine examination and maintenance.
In the pharmaceutical industry, guards need to be removed from machinery more often than in other industries due to the need for regular thorough cleaning. Hinged guards are beneficial because they provide rapid access and cannot be mislaid or replaced incorrectly. Guards are typically manufactured from polycarbonate or stainless steel with polycarbonate infill or inset viewing panels. Sometimes stainless steel mesh infill is used for the guards, depending on the process, hazards and cleaning requirements, as this achieves a lightweight guard with good process visibility.
Of course, these removable guards must be fitted with interlock switches to ensure access to hazards parts is prevented. In some cases the switches will signal to the safety-related control system that the guards are open and the hazardous movement will be stopped immediately. However, it might be necessary to fit interlocks that prevent access because a period of time is needed to allow the process to slow down – or for hot surfaces to cool or cold surfaces to warm up. Today’s safety-related control systems can also permit guards to be opened without stopping the process completely, as the control system maintains the process speed at a sufficiently low level that it is not hazardous.
If lubrication points are situated behind the guards or on unguarded parts of the machinery, they can often be relocated outside the guarding to avoid the need to remove guards for lubrication.
There may well be some guards that do need to be removed for more thorough examination, cleaning or maintenance, and these removable guards should be designed and manufactured to have sufficient strength and stiffness that they can be secured with the minimum number of fasteners (the fewer the fasteners, the less time is needed to remove the guard). Furthermore, BS EN ISO 14120 requires that the fasteners must be of a retained type so they cannot be mislaid when the guards are removed, and this standard also prohibits the use of quick-release fasteners that are accessible from outside the guarded area.
At the time of writing (June 2020) the UK has left the EU but is in a transition period until the end of the year. For the time being, therefore, new machines commissioned in the UK must still be CE Marked to the European Machinery Directive. Trade negotiations are ongoing so it is currently uncertain what the situation will be from 2021 onwards; it may be that the UK shadows the CE Marking system or adopts its own system – which, in all likelihood, will be very similar.
CE Marking is not retrospective so should not normally be applied to existing machines. However, if existing machines are modified or combined with other machines, then CE Marking may be necessary. Furthermore, there are some circumstances under which retrofitted machine guards must be CE Marked as ‘safety components.’
Machine guarding compliance surveys
Pharmaceutical manufacturers who are uncertain whether their machine guarding complies with PUWER and the relevant standards can request a free initial consultation from Procter Machine Safety. After an initial telephone consultation, Procter’s safety engineers can make an appointment for a site visit to assess the guards. As part of the free survey, the safety engineers provide a short written report that identifies areas of non-compliance and actions that can be taken to comply with the law, reduce risk and provide a safe working environment. Importantly, rather than just leaving a list of ‘problems’, the company can also provide ‘solutions’ in the form of a quote and, if requested, guards can be designed, manufactured and installed. If the need is urgent, guards can be installed within as little as two weeks from the initial enquiry.
Working from height
Although falls from height in the pharmaceutical industry seldom result in fatalities, falls can result in major injuries such as broken limbs and fractured skulls. Under the Work at Height Regulations, employers have a legal obligation to safeguard their employees from risks relating to working at height.
Where high-level access is required regularly for routine tasks, employers should install permanent safe means of access. Platforms and stairways with appropriate handrails, guard rails and toe boards may be necessary in order to control the risk of falls so far as is reasonably practicable. A formal risk assessment will help in deciding whether or not the cost of such installations is justified.
Procter’s safety specialists are familiar with the risks associated with working from height, as well as the Work at Height Regulations and applicable standard (BS EN ISO 14122 parts 1 to 4). If pharmaceutical manufacturers are in any doubt whether access platforms, stairs and fixed ladders are necessary, Procter’s experts can discuss the issues and, if requested, conduct a risk assessment and provide a quotation for designing, manufacturing and installing bespoke access equipment.
These are all available free of charge on request or to download.
Email: [email protected]
Risk Assessment Calculator
Based on the requirements of BS EN ISO 12100 and designed to be simple to use.
Safety Distance Calculator
Establishes machine guard safety distances and heights in accordance with BS EN ISO 13857.
Guide to Machine Guarding Standards
A list of current machine guarding standards and advice for designing standards-compliant machine guards.
Guide to the New Machinery Directive 2006/42/EC
To help companies comply with the Directive that came into force on 29 December 2009.
White paper: CE Marking of Machine Guards
Explains the requirements relating to CE marking of guards under the Machinery Directive.
White paper: Machinery Directive and Fixings for Fixed Guards
Explains the recently amended requirements for fixings for fixed guards.
White paper: EN 349, Minimum Gaps to Avoid Crushing
Explains the requirements in the standard for minimum gaps to prevent crushing. Note: BS EN ISO 13854:2019 has superseded BS EN 349 but the two standards are very similar and the advice contained in this white paper remains relevant.
White paper: Differences Between BS EN 953 and BS EN ISO 14120
Explains what changes were introduced in BS EN ISO 14120 when it replaced BS EN 953.
White paper: The 2014 Edition of PD 5304
Explains the changes in the 2014 edition of BSI’s Guidance on safe use of machinery.
White paper: BS EN ISO 14122
Explains the requirements in the four-part standard for permanent means of access to machinery.
White paper: Conveyor Guarding
Discusses conveyor hazards, regulations, standards and how to install guards without adversely affecting productivity.
White paper: Acoustic Enclosures
Explains how acoustic enclosures can assist in meeting legal obligations for safeguarding workers from excessive noise.
White paper: PUWER
Explains the requirements for machinery guarding with respect to the Provision and Use of Work Equipment Regulations 1998.
White paper: PD ISO TS 18837:2018
Discusses the implications for machine guarding applications of the official guidance on trapped key interlocking.
Machine Accident Investigation Kit
To help companies meet their statutory obligations and prevent future accidents.
Procter Machine Safety (site surveys, design, manufacture and installation of bespoke machine guards, including electrical integration where necessary, plus access platforms, walkways and fixed ladders)
Tel: 02920 855 758
Tel: 0345 086 9001
Health and Safety Executive
Tel: 0300 003 1747
Note: many publications are now available to download for free as PDF files.
Tel: 0333 202 5070
Definitive list of standards harmonised to the Machinery Directive 2006/42/EC, official guide to the application of the Machinery Directive and guidance on ergonomics.